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Eurofeedback High Voltage Electronic

⚠️ Moderate Risk

FEI: 3008866066 • Lisses, Essonne • FRANCE

FEI

FEI Number

3008866066

📍

Location

Lisses, Essonne

🇫🇷

Country

FRANCE
🏢

Address

1 rue du Maconnais, , Lisses, Essonne, France

Moderate Risk

FDA Import Risk Assessment

35.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
7/6/2011
Latest Refusal
6/14/2011
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

5083×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
7/6/2011
79MWYSYSTEM, MICROWAVE, HAIR REMOVAL
118NOT LISTED
508NO 510(K)
Division of Southeast Imports (DSEI)
6/14/2011
79MWYSYSTEM, MICROWAVE, HAIR REMOVAL
508NO 510(K)
Division of Southeast Imports (DSEI)
6/14/2011
79MWYSYSTEM, MICROWAVE, HAIR REMOVAL
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Eurofeedback High Voltage Electronic's FDA import refusal history?

Eurofeedback High Voltage Electronic (FEI: 3008866066) has 3 FDA import refusal record(s) in our database, spanning from 6/14/2011 to 7/6/2011.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Eurofeedback High Voltage Electronic's FEI number is 3008866066.

What types of violations has Eurofeedback High Voltage Electronic received?

Eurofeedback High Voltage Electronic has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Eurofeedback High Voltage Electronic come from?

All FDA import refusal data for Eurofeedback High Voltage Electronic is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.